Monday 2 January 2012

Effect of FSS Regulations on food product standards and food additives

January 02, 2012

The Food Safety and Standards Act, 2006
The food processing industry is widely recognised as the 'sunrise industry' in India and is of enormous significance for India’s development because it is a vital linkage between the industry and agriculture.

Earlier the food processing industry in India was governed or regulated by several Acts and orders to safeguard food safety and the health of the consumer. But due to variation in the specifications / standards in different Acts / Orders, and administration by different departments and ministries, there were implementation problems and less importance was given to safety standards over a period of time. The food industry was facing problems as different products were governed by different orders and ministries and the rules and regulations in the country needed consolidation.

The Food Safety and Standards Act 2006 was introduced to overcome these shortcomings and to give more importance to safety standards. This Act consolidates the laws relating to food and establishes the FSSA for laying down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption. The Act integrates eight different food related statutes. The Act also aims to establish a single-reference point for all matters relating to food safety and standards, by moving from multi-level, multi-departmental control to a single line of command.

Standards and additives prior to FSSA
Food laws and product standards prior to FSSA were often inconsistent and overlapping e.g., there were ambiguities and overlap between the standards laid down in PFA and FPO. The PFA laid emphasis on the prevention of adulteration of foods; PFA was prescriptive and recipe-based (PFA laid down over 300 recipes of products), which restricted product innovation and choice to the consumers. Proprietary formulations were not permitted for standard conventional products. PFA specified a list of additives that can be used in food products. Use of any other additive would render the product as adulterated even if the additive is safe. Under PFA, the Central Committee for Food Standards (CCFS) was the expert body that recommended mandatory national food standards. It had representation from the Central government, state governments, consumer organisations, research institutions, laboratories, and industry. There were various sub-committees under CCFS, which make recommendations on food standards in the respective sector.

Present status of standards, additives under FSSA
The Food Safety and Standards Rules have been notified on May 5, 2011, and FSSA has been notified on August 5, 2011. The food authority while drawing up the regulations has tried to integrate erstwhile Acts, Rules, Orders, in line with the mandate of the FSSA. The Authority has not introduced new standards at this stage since it would require detailed risk assessment, examination of risk management options, consideration by the scientific panels / committee and final approval by the food authority and Central government as the Act mandates for legislation to be based primarily on scientific evidence and risk assessment. To do this task, several scientific panels and an overseeing scientific committee have been constituted.

The food authority has constituted the following 8 scientific panels in terms of Section 13 of the Act, consisting of independent scientific experts:
1. Functional foods, nutraceuticals, dietetic products and other similar products;
2. Method of sampling and analysis;
3. Food additives, flavourings, processing aids and materials in contact with food;
4. Contaminants in food chain;
5. Biological hazards;
6. Pesticides and antibiotic residues;
7. Labelling and claims / advertisements;
8. Genetically-modified organisms and foods

FSSAI approach for drawing up / revision of standards
The new regulations / amendments will be made in the FSSAI standards / regulations from time to time and is an ongoing process. As per a draft paper shared by FSSAI for discussion on approach for drawing up / revision of standards; some of the objectives of developing food standards are – (1)To provide more effective food safety regulations and reduce the level of food-borne illnesses in India. (2) To continuously review and update the standards of food in line with progress of science and its capability to understand and prevent food-borne illnesses. (3) To develop regulations that are less prescriptive and easier to comply, which are more effectively monitored and implemented. (4) To encourage growth of the food sector by providing regulatory windows for innovative products to meet consumer choice and health, while providing highest level of protection to the consumer. While establishing standards, FSSAI will endeavour to (a) Develop standards which are easier to understand and make amendment more straightforward. (b) Replace standards which regulate individual foods with standards that apply across all foods or a range of foods. (c) Remove inconsistent / redundant regulations where new regulations are in conflict or superseded. (d) Resolve interface issues across various pieces of regulatory actions that arise with relation to foods. (e) Promote industry codes of practice to supplement regulation. (f) Promote consumer education as a cost-effective regulatory option to labelling requirements. (g) Facilitate harmonisation of standards with India’s trading partners and the international community-based on best practice.

New food categorisation system and food additives
FSSA is working on developing new food categorisation system for regulation of food additives with an objective of replacing standards for individual food and harmonisation with Codex food categorisation system and to remove difficulties like ambiguities arising due to the complicated current structure, practice of allowing additives on basis of individual product instead of product categories, absence of a comprehensive list of additives which are proven to be safe and would be allowed, to be used in most foods in general on GMP basis practice of listing additives according to their functional classes.

The main problem with the current system is the practice of allowing additives according to specific products and not categories. This is the main issue that needs to be corrected immediately in the new FSS Regulations. There are 15 tables under Appendix A which together list about 186 products / product categories. Some of them are specific products while some are categories. In many cases, the same product / category appears in 2/3 different tables and separate set of additives are mentioned against the same product in each of these.

Description of food categories and their coverage
While developing the new food categorisation system (product standards and additives) the authority is working on broad category numbering system that has been based on the Codex structure and this is also being followed in most modern laws across the world. It will bring in a harmonised structure and will also make it easy to relate to specific discussions on products and additives in Codex meetings. As far as the subcategories are concerned, efforts are being made to broad base the system so that each and every product currently listed in appendix finds a subcategory. Also new subcategories have been added to include products which are widely available in the Indian market but are not categorised under any standard or additive listing.

As per the FSS Act new regulations are also being made for the manufacture, distribution or trade of any novel foods, GM foods, irradiated foods, organic foods, foods for special dietary uses, functional foods, nutraceuticals, health supplements, proprietary foods, etc.

Food additives
FSSA has suggested 27 functional classes of food additives along with their technological purpose and as a single additive can be used for different technological purposes, the manufacturer shall declare the most appropriate functional class of additive. In the new categorisation system, products have been put under broad generic categories and subcategories so that the additives currently allowed to be used in one single product may also be allowed in similar products or proprietary foods falling under same categories. All food additives subject to the provisions of GMP Standard shall be used under conditions of GMP, which include the following; a) the quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect; b) the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technical effect in the food itself, is reduced to the extent reasonably possible; and, c) the additive is of appropriate food grade quality and is prepared and handled in the same way as a food ingredient.

While we are developing food standards and additives based on scientific knowledge, risk assessment and harmonisation with Codex, adequate care should be take to cover indigenous products and new standards should focus on food safety and promote innovative and better offerings to the consumer. By the time new food product standards and categorisation systems are being worked out, the additives and standards approvals pending after shift from PFA to FSSA should be notified after due consideration so that the industry continues to innovate during this transition period.

(The author is principal scientist, foods, Dabur Reasearch & Development Centre:       


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